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Absorbable gelatin: Drug information

Absorbable gelatin: Drug information
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For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Gel-Flow NT;
  • Gelfilm;
  • Gelfoam;
  • Gelfoam Compressed Size 100;
  • Gelfoam Dental Pack Size 4;
  • Gelfoam Sponge;
  • Gelfoam Sponge Size 100;
  • Gelfoam Sponge Size 200;
  • Gelfoam Sponge Size 50
Pharmacologic Category
  • Hemostatic Agent
Dosing: Adult
Hemostasis

Hemostasis (Gelfoam, Gel-Flow NT): Note: Use minimum amount of product necessary to produce hemostasis; once hemostasis attained, excess product should be removed.

Dental sponge: Insert rolled sponge (dry or wet) into cavity or socket; apply light finger pressure for 1 to 2 minutes

Sponge: Apply appropriate size (dry or wet) with moderate pressure directly to bleeding site until bleeding stops; if first application does not stop bleeding, additional applications may be used with a new sponge

Powder: Apply paste to bleeding surface; remove excess paste when bleeding has stopped. Consult manufacturer's labeling for additional information.

Neurosurgery, thoracic, or ocular surgery

Neurosurgery, thoracic, or ocular surgery (Gelfilm): Use as directed per manufacturer's labeling.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported for Gelfoam powder during cardiopulmonary bypass surgery unless otherwise indicated.

>10%: Cardiovascular: Atrial fibrillation (13%)

1% to 10%:

Cardiovascular: Atrial flutter (2%), heart block (1%), heart failure (4%), peripheral vascular disease (2%), ventricular tachycardia (2%)

Infection: Wound infection (6%)

Respiratory: Pneumothorax (2%), respiratory failure (2%)

Miscellaneous: Fever (1%)

<1%:

Cardiovascular: Angina pectoris, arteriosclerosis, atrial arrhythmia, atrioventricular nodal arrhythmia, cardiac insufficiency, cardiac tamponade, cardiogenic shock, cardiomyopathy, deep vein thrombosis, endocarditis, hypotension, mesenteric artery occlusion, mesenteric venous occlusion, mitral valve disease, premature ventricular contractions, supraventricular tachycardia, thrombophlebitis, thrombosis

Endocrine & metabolic: Dehydration, heavy menstrual bleeding, hypovolemia, metabolic acidosis

Gastrointestinal: Gastrointestinal hemorrhage

Genitourinary: Anuria

Hematologic & oncologic: Anemia, thrombocytopenia

Hypersensitivity: Anaphylaxis

Infection: Sepsis

Nervous system: Cerebral infarction, delirium (tremens), stupor, visual hallucination

Ophthalmic: Retinal artery occlusion

Renal: Altered kidney function, increased serum creatinine

Respiratory: Aspiration pneumonia, chest congestion, hypoxia, pleural effusion, pulmonary infiltrates

Miscellaneous: Abnormal healing

Postmarketing:

Gastrointestinal: Gastrointestinal disease (including bowel dysfunction; laminectomy)

Genitourinary: Bladder dysfunction (laminectomy), erectile dysfunction (laminectomy)

Hematologic & oncologic: Hematoma

Infection: Abscess, bacterial infection, toxic shock syndrome (nasal surgery)

Local: Injection-site granuloma (brain; brain implant surgery), localized edema (includes encapsulation of fluid and fluid accumulation in the brain and spinal cord)

Nervous system: Arachnoiditis (laminectomy), cauda equina syndrome (laminectomy), foreign body reaction, headache (laminectomy), hydrocephalous (product migration following neurosurgery), increased intracranial pressure (brain implant surgery), meningitis (laminectomy), pain (laminectomy), paresis (laminectomy), paresthesia (laminectomy), spinal cord compression (brain implant surgery), spinal cord injury (spinal stenosis; laminectomy)

Neuromuscular & skeletal: Tendinopathy (prolonged fixation of tendon post severed tendon repair)

Otic: Hearing loss (tympanoplasty)

Miscellaneous: Fibrosis (tendon repair)

Contraindications

Gelfilm: Hypersensitivity to porcine collagen.

Gelfoam, Gel-Flow NT: Hypersensitivity to porcine collagen; intravascular placement (embolus risk); closure of skin incisions (interferes with healing)

Warnings/Precautions

Concerns related to adverse effects:

• Hydrocephalus/cerebrovascular fluid retention: Hydrocephalus and cerebrovascular fluid retention requiring a re-intervention to remove Gelfoam residue have been reported; complications may occur several months after use.

• Hypersensitivity reactions: Acute, severe hypersensitivity reactions, including life-threatening/fatal anaphylactic reactions, have been reported with absorbable gelatin products. Patients with history of allergy to porcine products may be at increased risk of severe reactions. Immediately discontinue if anaphylaxis occurs.

Disease-related concerns:

• Infection: Do not use in the presence of infection and use with caution in contaminated areas of the body; if signs or symptoms of infection or abscess develop in an area where placed, reoperation may be necessary to remove material and allow drainage.

• Postpartum bleeding/menorrhagia: Do not use to control postpartum bleeding or menorrhagia.

Other warnings/precautions:

• Appropriate use: Products are not a substitute for surgical technique or conventional hemostasis procedures and should not be used for primary treatment of coagulation disorders. Use minimum amount necessary; remove once hemostasis is attained whenever possible following laminectomy procedures and from foramina in bone. Do not pack in bony cavities or overpack cavities; Gelfoam and Gel-Flow NT expand by absorbing fluid and may interfere with normal function of neighboring structures. It is not recommended to saturate product with an antibiotic solution or dust with antibiotic powder. Do not use in conjunction with methylmethacrylate adhesives. Avoid concomitant use of Gelfoam and Gel-Flow NT with autologous blood salvage circuits. Positioning of the patient resulting in negative peripheral venous pressure during a procedure has been reported to be a contributing factor resulting in life-threatening thromboembolic events. Do not place Gelfoam in the vicinity of the cerebral ventricular space (where there is a possibility of a cerebrospinal fluid fistula to the target bleeding site) or as a tissue substitute to repair tissue defects of the dura or cranium; may migrate from cerebrospinal fluid (CSF) surgical sites into the cerebral ventricular space and compromise the CSF circulation.

• Sterilization: Products cannot be resterilized; unused, opened products should be discarded.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Film, External:

Gelfilm: (1 ea)

Film, Ophthalmic:

Gelfilm: (6 ea)

Miscellaneous, External:

Gelfoam Compressed Size 100: (6 ea)

Gelfoam Dental Pack Size 4: (2 ea)

Gelfoam Sponge: 12-7 MM (12 ea)

Gelfoam Sponge Size 50: (4 ea)

Gelfoam Sponge Size 100: (6 ea)

Gelfoam Sponge Size 200: (6 ea)

Powder, Mouth/Throat:

Gelfoam: (1 g)

Prefilled Syringe, External:

Gel-Flow NT: (1 ea)

Generic Equivalent Available: US

No

Pricing: US

Misc (Gelfoam Sponge External)

12-7 mm (per each): $11.43

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Sterile technique should be used when removing product from package. Refer to product labeling for additional administration information.

Sponge (Gelfoam): Cut sponge to required size; dry or wet sponge may be applied to bleeding site.

Dry sponge: Manually compress dry sponge prior to application to bleeding site; hold in place with moderate pressure until bleeding stops.

Wet sponge: Immerse sponge in sterile saline or sterile topical thrombin solution, remove from solution, squeeze between gloved fingers to remove air bubbles, and return to saline solution until needed. Sponge should return to original size after air is expelled. Wet sponge may be blotted to dampness on gauze prior to application and may be held in place with a small gauze sponge until bleeding stops. Remove gauze from sponge by wetting with a few drops of sterile saline.

Note: Sponge is absorbed completely within 4 to 6 weeks. Sponge is liquefied in 2 to 5 days when applied to mucosal regions.

Powder:

Gel-Flow NT: Saturate Gelfoam powder with sterile saline or thrombin; smear, fill, or press mixture against bleeding surface until bleeding stops; may leave in place at bleeding site if necessary or may be left in place when applied to mucosal surfaces until it liquefies. May close wound over mixture.

Gelfoam: Prepare a puttylike paste by placing the powder into sterile beaker and adding ~3 to 4 mL of sterile saline.

Administration: Pediatric

Topical: Sterile technique should be used when removing product from package.

Film: Immerse film in sterile saline solution and allow it to soak until it becomes pliable; it may then be cut to desired size and shape without difficulty and applied. See product labeling to application details.

Sponge (Gelfoam): Cut sponge to required size; dry or wet sponge may be applied to bleeding site.

Dry sponge: Manually compress dry sponge prior to application to bleeding site; hold in place with moderate pressure until bleeding stops

Wet sponge: Immerse sponge in sterile saline or sterile topical thrombin solution, remove from solution, squeeze between gloved fingers to remove air bubbles, and return to saline solution until needed. Sponge should return to original size after air is expelled. Wet sponge may be blotted to dampness on gauze prior to application and may be held in place with a small gauze sponge until bleeding stops. Remove gauze from sponge by wetting with a few drops of sterile saline.

Note: Sponge is absorbed completely within 4 to 6 weeks. Sponge is liquefied in 2 to 5 days when applied to mucosal regions.

Powder:

Gel-Flow NT: Saturate Gelfoam powder with sterile saline or thrombin prior to application; smear, fill, or press mixture against bleeding surface to control bleeding; when bleeding stops remove excess; may leave in place at bleeding site if necessary or may be left in place when applied to mucosal surfaces until it liquefies

Gelfoam: Prepare a puttylike paste prior to application. Smear or press mixture against bleeding surface to control bleeding; when bleeding stops remove excess; may leave in place at bleeding site if necessary or may be left in place when applied to mucosal surfaces until it liquefies.

Use: Labeled Indications

Hemostasis (Gelfoam, Gel-Flow NT): Adjunct to provide hemostasis in surgical procedures (except ophthalmic) when control of bleeding by pressure, ligature, and other conventional techniques are ineffective.

Note: May be moistened with sterile saline or sterile topical thrombin.

Neurosurgery, thoracic, or ocular surgery (Gelfilm): Adjunct in neuro, thoracic, or ocular surgeries to promote tissue repair and/or prevent adhesions.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

When administered topically, gelatin is completely absorbed; however, the amount of gelatin available systemically following topical application is unknown.

Mechanism of Action

Arrests bleeding by forming artificial clot and producing mechanical matrix which facilitates clotting

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Gelfoam;
  • (AR) Argentina: Gelfoam;
  • (AU) Australia: Gelfoam;
  • (BE) Belgium: Gelfoam;
  • (BG) Bulgaria: Gelaspon;
  • (BR) Brazil: Gelfoam;
  • (CH) Switzerland: Gelfoam;
  • (CL) Chile: Gelfoam;
  • (CO) Colombia: Gelfoam;
  • (CZ) Czech Republic: Gelaspon | Spongostan | Spongostan Anal | Spongostan stand;
  • (DE) Germany: Curaspon | Gelaspon | Spongostan | Stypro;
  • (EE) Estonia: Spongostan;
  • (FR) France: Gelfoam;
  • (GB) United Kingdom: Spongostan;
  • (HK) Hong Kong: Gelfoam;
  • (HU) Hungary: Gelaspon | Spongostan | Spongostan Anal | Spongostan Special;
  • (IE) Ireland: Gelfoam;
  • (IL) Israel: Gelfoam;
  • (IN) India: Spongostan;
  • (IT) Italy: Spongostan;
  • (JP) Japan: Gelfoam;
  • (KR) Korea, Republic of: Gelfoam | Hemospon | Novacol fibrillar | Spongostan | Spongostan Anal | Spongostan Special | Spongostan stand.;
  • (LT) Lithuania: Gelaspon | Spongostan;
  • (LU) Luxembourg: Gelfoam;
  • (LV) Latvia: Gelaspon | Spongostan;
  • (MX) Mexico: Gelfoam;
  • (MY) Malaysia: Gelfoam;
  • (NZ) New Zealand: Gelfoam;
  • (PL) Poland: Gelaspon | Spongostan;
  • (PR) Puerto Rico: Gelfoam | Surgifoam;
  • (PT) Portugal: Spongostan | Spongostan Anal | Spongostan Special;
  • (SA) Saudi Arabia: Gelfoam;
  • (SE) Sweden: Gelita spon;
  • (SG) Singapore: Gelfoam;
  • (SK) Slovakia: Gelaspon | Spongostan;
  • (TH) Thailand: Spongostan | Spongostan Anal | Spongostan Special | Spongostan standard;
  • (TW) Taiwan: Gelfoam sponge
  1. Gelfilm (gelatin [absorbable]) [prescribing information]. New York, NY: Pfizer Inc; November 2020.
  2. Gel-Flow NT (gelatin [absorbable]) [prescribing information]. New York, NY: Pfizer Inc; May 2022.
  3. Gelfoam (gelatin [absorbable]) compressed sponge [prescribing information]. New York, NY: Pfizer Inc; May 2021.
  4. Gelfoam (gelatin [absorbable]) dental sponge [prescribing information]. New York, NY: Pfizer Inc; November 2020.
  5. Gelfoam (gelatin [absorbable]) powder [prescribing information]. New York, NY: Pfizer Inc; May 2021.
  6. Gelfoam (gelatin [absorbable]) sponge [prescribing information]. New York, NY: Pfizer Inc; May 2021.
  7. Surgifoam (gelatin [absorbable]) [prescribing information]. Somerville, NJ: Ethicon Inc; August 2014.
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